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Question Text Author Response Custom
Submission Question ID
Please complete the following questions in accordance with theInternational Committee of Medical Journal Editors'
recommendations on data sharing in clinical trials (guidelines and examples are available here
Will individual participant data be available (including data dictionaries)?
Anonymised data relating to clinical and functional outcomes may be available on request.
54
What data in particular will be shared?
(Examples include all individual participant data after
deidentification, only participant data that underlies the results, or not available.)
No patient identifiable data shall be
shared. 55
What other documents will be available? Nil. 56
When will data be available (start and end dates)? From date of publication. Our ethical approval only allows data to be held for a maximum of 10 years post-study (2028).
57
With whom? (Examples include anyone who wishes to access the data, researchers who provide a proposal, or not applicable.)
Researchers who provide a proposal. 58
For what types of analyses? Systematic review and meta-analyses. 59
By what mechanism will data be made available? Excel file with fully anonymised and de-identified data.
60
